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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GENERATOR 103

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CYBERONICS, INC. PULSE GENERATOR 103 Back to Search Results
Model Number 103
Event Date 09/17/2012
Event Type  Malfunction  
Event Description

During review of programming history the patient was found to have high impedance. The high impedance appears to be on the date of implant and was resolved two days later however the patient identity is unknown and it has not been confirmed that is the date of implant. Attempts for additional information have been unsuccessful.

 
Manufacturer Narrative

Analysis of programming.

 
Event Description

Product analysis was completed for the returned lead. It was observed that the lead was received still inserted into the generator. Prior to decontamination a continuity check was performed while the lead pin was still inserted into the lead and the continuity check verified there was proper contact between the setscrew and the lead pin was present. Inspection of the lead pin found there were three sets of setscrew marks. One of the marks was near the end of the lead pin which indicated that the lead pin was not fully inserted at one point in time. It appeared that the setscrew mark near the end of the tip of the generator were most likely related to inadequate pin insertion. Therefore it appears that the high impedance captured in this report were likely resolved during follow-up surgery where the lead pin was re-inserted into the generator. Only product analysis information related to this pin insertion event are captured in this report as the setscrew marks were the only relevant part of the analysis. The remainder of the product analysis of the lead is captured in mfg. Report #1644487-2018-00021.

 
Event Description

The lead's product information was identified during an investigation into a separate high impedance event which was reported in mfg. Report #1644487-2018-00021. The lead was received after being explanted and is pending analysis.

 
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Brand NamePULSE GENERATOR 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3372026
Report Number1644487-2013-02946
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation
Type of Report Initial
Report Date 03/23/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/26/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/10/2014
Device MODEL Number103
Device LOT Number202066
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/26/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured11/15/2005
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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